Efficacy of Fish Oil on Serum TNFα, IL-1β, IL-6, Oxidative Stress Markers in Multiple Sclerosis Treated With Interferon Beta 1-b
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- TNF alpha
研究概览
简要总结
The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in MS.
详细描述
Current research findings suggest that Omega-3 polyunsaturated fatty acids (PUFA) such as eicosahexanoic acid (EPA) and docosahexaenoic acid (DHA) contained in fish oil may have anti-inflammatory, antioxidant and neuroprotective effects. The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines levels, oxidative stress markers and disease progression in MS. 50 patients with relapsing-remitting MS were enrolled. The experimental group received orally 4 g/day of fish oil for 12 months. The primary outcome was serum TNFα levels; Secondary outcomes were IL-1β, IL-6, nitric oxide catabolites, lipoperoxides, progression on the expanded disability status scale (EDSS) and annualized relapses rate (ARR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had clinically definite and magnetic resonance image supported MS
- •Had at least one relapse in the year before entry into the study
- •EDSS score of 0-5
- •Treated with subcutaneous 250 μg interferon beta-1b (Betaseron, Bayer)
排除标准
- •they were taking another supplement
- •had progressive forms of MS
- •had history of severe depression
- •had history of acute liver or renal dysfunction
- •had history of tobacco, drug or alcohol abuse
- •had intolerance, contraindication or allergy to fish oil
结局指标
主要结局
TNF alpha
时间窗: 3 months
Serum TNF alpha levels, at baseline, 3, 6, 9 and 12 months.
次要结局
- IL-1 beta, IL-6, Lipoperoxides, nitric oxide(3 months)
研究者
Genaro Gabriel Ortiz
Investigador titular D
Coordinación de Investigación en Salud, Mexico